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The Effect of Stress on Neuroendocrine Markers and Functional Connectivity in Children and Adolescents with Depressive and Anxiety Disorders

The Effect of Stress on Neuroendocrine Markers and Functional Connectivity in Children and Adolescents with Depressive and Anxiety Disorders

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00032507
Enrollment
90
Registered
2023-08-28
Start date
2024-01-17
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F32.1 F32.2 F32.3 F33.1 F33.2 F33.3 F40.0 F40.00 F40.01 F40.1 F41.0

Interventions

Group 1: Children and adolescents with a principal diagnosis of depressive disorder attend 2 appointments: 1) A structured clinical examination with psychometric procedures. 2) An MRI session encom

Sponsors

Klinik und Poliklinik für Kinder- und Jugendpsychiatrie der Universität Regensburg am Bezirksklinikum Regensburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 17 Years

Inclusion criteria

Inclusion criteria: General inclusion criteria - Sufficient understanding of the German language - Informed consent of the study participants and their legal guardians - Age at the beginning of the study participation: 12-17 years Inclusion criteria patient group depressive disorders - Primary diagnosis of a depressive disorder according to the diagnostic criteria of the DSM-V classification and ICD-10 (Moderate depressive episode (F32.1), Major depressive episode without psychotic symptoms (F32.2), severe depressive episode with psychotic symptoms, Recurrent depressive disorder, current moderate episode (F33.1), Recurrent depressive disorder, current major episode without psychotic symptoms (F33.2), Recurrent depressive disorder, current major episode with psychotic symptoms (F33.3)) Inclusion Criteria Patient Group Depressive disorders with comorbid anxiety disorder. - Primary diagnosis of depressive disorder according to "Inclusion criteria patient group depressive disorders". - Additional diagnosis of an anxiety disorder according to the diagnostic criteria of the DSM-V classification and ICD-10 (agoraphobia (ICD-10 F40.0) without/with details a panic disorder (F40.00, F40.01), social phobias (F40. 1), panic disorder (F41.0), generalized anxiety disorder (F41.1), emotional disorder with separation anxiety of childhood (F93.0), disorders with social anxiety of childhood (F93.2), generalized anxiety disorder of childhood (F93.80) Inclusion criteria healthy control group - No psychiatric and neurological pre-existing conditions - No presence of a mental disorder requiring treatment - No current or past outpatient, partial hospitalization, or full hospitalization psychiatric or psychotherapeutic interventions

Exclusion criteria

Exclusion criteria: General exclusion criteria - Pre-existing neurological or endocrinological disorders - Known genetic syndromes - Past traumatic brain injury - Use of glucocorticoid-containing medications - Pregnancy or lactation - Premature pubertal development (pubertas precox vera) due to hormonal status deviating from the norm (Brämswig & Dübbers, 2009) - Known intellectual impairment (IQ<80). - School education: Special school - Acute suicidal tendency - Other neurological disorders affecting brain development and physiology - Lack of consent - MRI-specific contraindications: metallic foreign objects, tattoos with metal-containing pigments, claustrophobia, pacemakers and defibrillator systems, cochlear implant, implanted insulin pumps, non-removable piercings made of magnetic materials. - At least one of the following mental disorders (current or past). o Psychotic disorder o Autism o Bipolar disorder o Anorexia nervosa o Substance dependence Exclusion Criteria Patient Group Depressive Disorders - Categorical diagnosis of anxiety disorder Exclusion criteria control group - Pre-existing psychiatric and neurological conditions - Presence of a mental disorder requiring treatment - Current or past outpatient, inpatient, or partial inpatient psychiatric or psychotherapeutic interventions - Use of psychotropic drugs and neuroleptics

Design outcomes

Primary

MeasureTime frame
1. fMRI - structural connectivity differences between relevant areas before and after stress induction are assessed by resting state scans - during stress induction by the MIST paradigm (control and stress condition) task-based fMRI scans are acquired - Using diffusion-weighted imaging (DTI), structural connectivity differences between relevant brain areas are assessed. 2. Determination of hormone concentrations (oxytocin. cortisol and alpha-amylase) by collecting saliva samples at eight different time points Psychosocial stress will be induced using a modified version of the Montreal Imaging Stress Task (MIST; Dedovic et al., 2005).

Secondary

MeasureTime frame
Physiological stress parameters: Recording of heart rate using a pulse oximeter. Psychological stress parameters: Subjective stress levels, anxiety, insecurity, tension, shame, guilt using the Visual Analogue Scale (VAS; Hellhammer & Schubert, 2012). Questionnaires and clinical interview: - Baseline interview on study-relevant data such as age/date of birth, nationality, weight, height, type of school, treatment setting if applicable, duration of illness if applicable, previous and current medication, self-injurious behavior - Mini-International Neuropsychiatric Interview for Children and Adolescents (M.I.N.I.-KID; Sheehan et al., 1998). - Social Phobia and Anxiety Inventory for Children (SPAIK; Melfsen et al., 2001) - German version of the Perth Alexithymia Questionnaire (PAQ; Jarvers et al., 2021) - Child Trauma Questionnaire Shortform (CTQ; Bernstein et al., 2003) - Pubertal Development Scale (PDS; Petersen et al., 1988) - Short version of the Experiences in Close Relationships Scale - Revised Child version (ECR-RC; Brenning et al., 2014) - Emotion Reactivity Scale (ERS; Nock et al., 2008) - Edinburgh Handedness Inventory (EHI; Oldfield, 1971) - Beck Anxiety Inventory (BAI; Beck et al., 1988) - Beck Depression Inventory (2nd edition) (BDI-II; Beck et al., 2006) - Child Version of the Positive and Negative Affect Schedule (PANAS-C-SF; Ebesutani et al., 2012). - Dissociation Tension Scale (DSS-4; Stieglmayer et al., 2009).

Countries

Germany

Contacts

Public ContactRomuald Brunner

Klinik und Poliklinik für Kinder- und Jugendpsychiatrie der Universität Regensburg am Bezirksklinikum Regensburg

romuald.brunner@medbo.de+49 (0) 941 / 941-4001

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026